Associate Director, CMC Regulatory Affairs - Small Molecules

Ladders; United States; Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

401(k) match

Life insurance

Disability coverage

Paid time off

Wellness programs

Job summary

Ladders is seeking an Associate Director, CMC Regulatory Affairs - Small Molecules to join its pharmaceuticals regulatory team. The role shapes global CMC strategy across development and commercialization, partnering with cross-functional teams to guide submissions and manage regulatory risk while aligning quality and manufacturing readiness throughout the product lifecycle.

Location is remote, US-based candidates only, with compensation at $150,000–$195,000 per year.

Qualifications

• Bachelor’s degree required in a scientific discipline related to pharmaceuticals or biotech.
• 8+ years of Regulatory Affairs experience focusing on CMC activities.
• Experience leading Health Authority interactions and global CMC submissions.

Responsibilities

• Develop global CMC regulatory strategies for development and commercialization of small molecules.
• Lead cross-functional teams, providing strategic regulatory guidance throughout product development.
• Assess regulatory risks and formulate mitigation strategies to support business objectives.
• Drive global CMC regulatory submissions and engage with Health Authorities on CMC matters.
• Ensure compliance of CMC documentation with regional regulatory expectations.
• Support inspection readiness and provide regulatory oversight for manufacturing processes and product quality.
• Coordinate contributions to CMC submissions and manage changes for post-approval activities.

Skills

Regulatory Affairs

CMC knowledge

Leadership

Global submissions

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related

Job description

For our client, we are seeking an Associate Director, CMC Regulatory Affairs - Small Molecules to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will shape global CMC regulatory strategy for small molecule programs across development and commercialization. The position partners closely with cross-functional stakeholders to guide submissions, manage regulatory risk, and support product quality and manufacturing readiness through every stage of the product lifecycle.

It will also be responsible for engaging with Health Authorities, ensuring compliance with regional expectations, and supporting post-approval changes that keep programs moving forward.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $150,000 – $195,000 annually

Responsibilities

• Develop global CMC regulatory strategies for clinical development and commercialization of small molecule products.
• Lead cross-functional teams, providing strategic regulatory guidance throughout product development.
• Assess regulatory risks and formulate mitigation strategies to support business objectives.
• Drive global CMC regulatory submissions and engage with Health Authorities on CMC matters.
• Ensure compliance of CMC documentation with regional regulatory expectations.
• Support inspection readiness and provide regulatory oversight for manufacturing processes and product quality.
• Coordinate contributions to CMC submissions and manage changes for post-approval activities.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, focusing on CMC activities.
• Strong expertise in small molecule products from IND to post-approval management.
• Demonstrated experience with global CMC regulatory submissions including INDs, CTAs, NDAs, and MAAs.
• Experience leading Health Authority interactions related to CMC topics.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.